Roche’s Gazyvaro (obinutuzumab) has been approved in Europe to treat the blood cancer chronic lymphocytic leukaemia (CLL).
The European Commission confirmed an earlier recommendation from regulators that backed the antibody in combination with chlorambucil chemotherapy as a first-line treatment in CLL patients who have another condition that make them unsuitable for intensive therapy will fludarabine.
The decision comes nearly nine months after Gazyvaro was approved in a similar indication in the US under the name Gazyva.
The drug is one of several new treatments for the blood cancer that have emerged in recent years. Just last week the European Medicines Agency (EMA) issued recommendations to both Janssen’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib) in CLL indications.
Both these drugs have also received approvals in the US this year: Imbruvica’s covering CLL patients who have failed first-line therapy and Zydelig’s covering three types of blood cancer, including relapsed CLL.
GlaxoSmithKline and Genmab also have a new CLL drug in the form of Arzerra (ofatumumab), which was approved in the US in April this year.
Regarding the European approval of Gazyvaro, Roche’s chief medical officer Dr Sandra Horning said the drug is a “new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions”.
Roche said it expects to launch the drug in a number of European countries later this year and the company also has hopes for Gazyvaro’s prospects in other types of blood cancer.
Specifically, the company is researching targets where anti-CD20 antibodies have been shown to be effective, and where future combination therapies may reduce or eliminate the need for chemotherapy.
Roche’s existing interests in blood cancer include MabThera/Herceptin (rituximab), which has been a big success for the company but is set to face competition from biosimilar versions due to the drug’s impending patent expiry.